UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044222 |
|---|---|
| Receipt number | R000050122 |
| Scientific Title | The Effect of mastication on periodontal disease and oral function |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/06/15 10:16:23 |
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Basic information
Public title
The Effect of mastication on periodontal disease and oral function
Acronym
The Effect of mastication on periodontal disease and oral function
Scientific Title
The Effect of mastication on periodontal disease and oral function
Scientific Title:Acronym
The Effect of mastication on periodontal disease and oral function
Region
| Japan |
Condition
Condition
periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of treatment for periodontal disease and training of chewing on periodontal disease and oral function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
an outcome related to evaluation for periodontal disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
treatment for periodontal disease combined with training of chewing
Interventions/Control_2
treatment for periodontal disease
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
need for treatment for periodontal disease and low masticatory performance
Key exclusion criteria
remaining teeth <20; posterior occlusal pairs <5; use for removable partial denture; need for periodontal surgery; having smoking a habit; any problem of temporomandibular joint; xerostomia; any problem of stomatognathic system; any of mental disease; receiving diet restriction; can not control contents of meal
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Komagamine |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4645
y.komagamine.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Komagamine |
Organization
Tokyo Medical and Dental University
Division name
Gerodontology and Oral Rehabilitation
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4645
Homepage URL
y.komagamine.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Lotte Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5404
rec.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050122
